Process Engineering Manager

Rubicon Research; Thane; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Rubicon Research in Thane, India, is seeking a Manager Process Engineering to lead process design, optimization, and scale-up for pharmaceutical formulations, including oral solids and nasal products, with strong scientific rationale.

You will drive technology transfer, support troubleshooting, manage quality risk reviews, review validation and batch records, and develop training programs for manufacturing and packing operations to sustain high yield and compliance.

Qualifications

• Experience in process design and optimization for pharma formulations.
• Knowledge of statistical process control (SPC) and quality risk management.
• Experience with scale-up from R&D to pilot and commercial production.

Responsibilities

• Design, review, and optimize manufacturing processes for oral solids and nasal formulations.
• Lead scale-up of formulations from R&D to commercial production with scientific rationale.
• Provide technical support to production, investigate process deviations and implement corrective actions.
• Develop training plans and technical competency programs for manufacturing staff.

Skills

Process design

Optimization

Scale-up

Technology transfer

Troubleshooting

SPC

Documentation

Training

Job description

Purpose

The Manager Process Engineering is responsible for leading process design, optimization, scale-up, technology transfer, troubleshooting, and continuous improvement initiatives with scientific way within a pharmaceutical formulation manufacturing facility. He is responsible for overseeing and optimizing pharmaceutical formulation manufacturing processes to ensure efficiency, compliance, quality, and cost-effectiveness.

Job Responsibilities / Deliverables

1. Process Design & Optimization in a scientific way

• Design, review, and optimize manufacturing processes for oral solids and nasal formulations.
• Lead scale-up of pharmaceutical formulations from R&D to commercial production with the scientific rational.
• Lead scale-up of pharmaceutical formulations from pilot scale to commercial production scale
• Optimize processes to reduce wastage and improve yield in manufacturing and packing operations of OSD and Nasal formulations.
• Optimize processes to reduce cycle time and minimize deviations.
• Conduct process capability studies and implement statistical process control (SPC).
• Evaluate and implement new technologies and equipment for process enhancement.
• Application of equipment know how to develop better process.

2. Troubleshooting & Technical Support

• Provide technical support to production during critical issues.
• Investigate process failures and implement corrective actions.
• Analyse trends and recommend preventive measures.
• Develop an expertise in all equipment used in manufacturing and packing operations. and train other people for the same.

3. Documentation

• Perform quality risk management of the process
• Review batch records to finalize and approve manufacturing process
• Review validation protocols and reports of the intended process.
• Handle change control, deviation investigations, and CAPA implementation

4. Training and Development

• Develop training plans and technical competency programs.
• Train production and other technical staff on equipment know how
• Train production and other technical staff on manufacturing processes.